Cleared Traditional

K803022 - CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC.

K803022 is the FDA 510(k) clearance for CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC. by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K803022 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Dec 1980
Decision
26d
Days
Class 1
Risk

K803022 is an FDA 510(k) clearance for the CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC.. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K803022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1980
Decision Date December 22, 1980
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSJ Culture Media, Selective And Non-differential

All 259
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K803022.
BUFFERED CHARCOAL YEAST EXTRACT AGAR
K802757 · Remel Co. · Jan 1981
SELECTIVE CHARCOAL YEAST EXTRACT AGAR
K802758 · Remel Co. · Dec 1980
MYCOLOGY CULTURE SYSTEM
K802946 · Orion Diagnostica, Inc. · Dec 1980
CDC ANAEROBE LAKED BL AGAR W/PARAMOMY.
K803024 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.
K803027 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
CLOSTRIDIUM DIFFICILE AGAR BASE
K802495 · Oxoid U.S.A., Inc. · Dec 1980